Sr. Clinical Research Associate

6 days ago

Gota Ahmedabad Gujarat, India zenovel Full time ₹ 3,17,000 - ₹ 13,05,290 per year

  • Take part in monitoring plan meeting

  • Overseeing the progress of a BA/BE studies or clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

  • Checking documents of CRO internal System audit at specified interval and related documents and CAPA

  • Perform on-site/remote monitoring visits i.e initiation, periodic monitoring, close out meetings, Bioanalytical visits and coordinate with project coordinators/project in-charges at different CROs for clinical trials & BA/BE studies.

  • Prepare the Monitoring Reports and taking follow up for the corrective actions and preventive actions taken by the site to solve all the observations. In addition, providing them suitable suggestions/recommendations if required.

  • Taking part in Audit strategy meeting

  • Conducing on-site/remote audit of BE CROs and phase-I facility

  • Preparation of Audit report and checklist

  • Compilation of the study source documents and submit to QMS for archival

  • Training of the new monitors/auditors and guide them for operation

  • Update the OneDrive with all soft copy of data

  • To perform other responsibility and duties delegated by the director operation and management.

Job Types: Full-time, Permanent

Pay: ₹317, ₹1,305,290.45 per year

Ability to commute/relocate:

  • Gota, Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (Required)

Experience:

  • BA/BE Monitoring: 4 years (Required)

Willingness to travel:

  • 50% (Required)

Work Location: In person

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